A new study set to assess a hemostasis screening protocol and cardiac periprocedural and postoperative hemostasis pathway for improving bleeding complications in children with Alagille syndrome (ALGS) and complex cardiac conditions is currently enrolling by invitation.
The researchers will examine if a novel screening protocol to detect preoperative bleeding conditions can actually decrease the occurrence of bleeding complications and mortality risk and whether the implementation of a novel screening protocol may cause thrombotic complications.
They will also investigate if children with ALGS and cardiac anomalies are more likely to be diagnosed with acquired von Willebrand syndrome as well. Next, children with ALGS with and without acquired von Willebrand syndrome and children without ALGS will be compared in terms of cardiac intra- and up to 48-hour postoperative bleeding complications, postoperative thrombotic complications within 30 days of surgery, and mortality.
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This single-site study aims to enroll 40 patients aged below 18 years who have complex cardiac conditions requiring pulmonary artery reconstruction, whereas those with a history of known bleeding disorders will not be considered.
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All participants will undergo hematology and bleeding disorder screening before surgery, as well as a detailed family screening for a history of bleeding by a genetic expert.
The primary outcome measures will include intraoperative through 24-hour postoperative blood product volume, chest tube output blood volume, and the number of participants with pulmonary hemorrhage.
The researchers will also monitor the number of thromboembolic events in patients with hematologic conditions intraoperatively through 30 days postoperatively as a secondary outcome measure.
The study, sponsored by Stanford University and conducted in collaboration with the Alagille Syndrome Alliance, is estimated to be completed by November 2024.
Reference
Decreasing hemorrhage risk in children with Alagille Syndrome. ClinicalTrials.gov. Last updated May 6, 2023. Accessed May 11, 2023.
